NCT06686680 · Spaulding Rehabilitation Hospital
Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy
(PTOA Knee)
What this study is about
This study is recruiting current or former athletes who had ACL reconstruction surgery over a year ago and have been diagnosed with knee osteoarthritis (OA). We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and strength, inflammation, and joint structure and integrity of the knee.
View original scientific description
This study is recruiting current or former athletes who had ACL reconstruction surgery over a year ago and have been diagnosed with knee osteoarthritis (OA). We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and strength, inflammation, and joint structure and integrity of the knee.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Previous ACL reconstruction using an autograft or allograft in the knee with PTOA
- Minimum of one year following ACL reconstruction surgery
- Between ages of 18 and 55
- No clear contraindication to complete protocol including mechanical symptoms which would limit ability to complete the study
- Score on KOOS for 2 of 4 domains (pain, symptoms, activities of daily living (ADL), quality of life (QOL)) of 85 or lower
- Primary pain is coming from the knee
- Diagnosis of PTOA based on clinical diagnosis and confirmation with radiographic evidence by a medical professional prior to study enrollment. If individuals have suspected OA based on impairments such as pain, they must have a score on KOOS for 2 of 4 domains (pain, symptoms, activities of daily living (ADL), quality of life (QOL)) of 85 or lower to participate in the study.
Exclusion criteria
- Have previously received injections to the knee joint within the past 3 months
- Women who are pregnant or those who are planning to become pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment. - Participants with neuropathy affecting sensation to pain
- Participants with a known underlying cardiac disease that could be affected by shockwave therapy
- Chronic rheumatological conditions, immunodeficiency, severe asthma, connective tissue disorder (i.e. Ehlers-Danlos Syndrome), or other medical conditions (ex. active malignancy, severe asthma) outside of PTOA that are known to impact inflammatory state or requiring chronic use of oral or intravenous immune modulatory medications. Asthma requiring use of inhalers only is not an exclusion criteria
- Neuropathy diagnosis that can affect response to pain
- No active use of oral steroids or anti-inflammatories at the time of enrollment
- Have bilateral ACL injury or reconstruction surgery, or have had ACL revision surgery
- No active malignancy and at least five years in remission
- Previous ESWT treatment using study treatment devices for management of knee osteoarthritis
- Have a pacemaker, bone screws, or any other metal implants that would prohibit participation in an MRI scan or EWST
- Non-English speaking individuals
Where
- Cambridge, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2025 · Source of record for eligibility and locations